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Introduction: Musculoskeletal (MSK) conditions constitute the highest burden of disease globally, with healthcare services often utilised inappropriately and overburdened. The aim of this trial is to evaluate the effectiveness of a novel clinical PAthway of CarE programme (PACE programme), where care is provided based on people's risk of poor outcome., Methods and Analysis: Multicentre randomised controlled trial. 716 people with MSK conditions (low back pain, neck pain or knee osteoarthritis) will be recruited in primary care. They will be stratified for risk of a poor outcome (low risk/high risk) using the Short Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMSPQ) then randomised to usual care (n=358) or the PACE programme (n=358). Participants at low risk in the PACE programme will receive up to 3 sessions of guideline based care from their primary healthcare professional (HCP) supported by a custom designed website (mypainhub.com). Those at high risk will be referred to an allied health MSK specialist who will conduct a comprehensive patient-centred assessment then liaise with the primary HCP to determine further care. Primary outcome (SF 12-item PCS) and secondary outcomes (eg, pain self-efficacy, psychological health) will be collected at baseline, 3, 6 and 12 months. Cost-effectiveness will be measured as cost per quality-adjusted life-year gained. Health economic analysis will include direct and indirect costs. Analyses will be conducted on an intention-to-treat basis. Primary and secondary outcomes will be analysed independently, using generalised linear models. Qualitative and mixed-methods studies embedded within the trial will evaluate patient experience, health professional practice and interprofessional collaboration., Ethics and Dissemination: Ethics approval has been received from the following Human Research Ethics Committees: The University of Sydney (2018/926), The University of Queensland (2019000700/2018/926), University of Melbourne (1954239), Curtin University (HRE2019-0263) and Northern Sydney Local Health District (2019/ETH03632). Dissemination of findings will occur via peer-reviewed publications, conference presentations and social media., Trial Registration Number: ACTRN12619000871145., Competing Interests: Competing interests: DB is director of a clinic providing specialist physiotherapy services in primary care. At the time of this trial, DB was the President of the Australian College of Physiotherapists, the organisation responsible for the training of specialist physiotherapists in Australia., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Recent guideline changes for cardiovascular disease (CVD) prevention medication have resulted in calls to implement shared decision-making rather than arbitrary treatment thresholds. Less attention has been paid to existing tools that could facilitate this. Decision aids are well-established tools that enable shared decision-making and have been shown to improve CVD prevention adherence. However, it is unknown how many CVD decision aids are publicly available for patients online, what their quality is like and whether they are suitable for patients with lower health literacy, for whom the burden of CVD is greatest. This study aimed to identify and evaluate all English language, publicly available online CVD prevention decision aids., Design: Systematic review of public websites in August to November 2016 using an environmental scan methodology, with updated evaluation in April 2018. The decision aids were evaluated based on: (1) suitability for low health literacy populations (understandability, actionability and readability); and (2) International Patient Decision Aids Standards (IPDAS)., Primary Outcome Measures: Understandability and actionability using the validated Patient Education Materials Assessment Tool for Printed Materials (PEMAT-P scale), readability using Gunning-Fog and Flesch-Kincaid indices and quality using IPDAS V.3 and V.4., Results: A total of 25 unique decision aids were identified. On the PEMAT-P scale, the decision aids scored well on understandability (mean 87%) but not on actionability (mean 61%). Readability was also higher than recommended levels (mean Gunning-Fog index=10.1; suitable for grade 10 students). Four decision aids met criteria to be considered a decision aid (ie, met IPDAS qualifying criteria) and one sufficiently minimised major bias (ie, met IPDAS certification criteria)., Conclusions: Publicly available CVD prevention decision aids are not suitable for low literacy populations and only one met international standards for certification. Given that patients with lower health literacy are at increased risk of CVD, this urgently needs to be addressed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the efficacy of an interactive smoking cessation decision-aid application (pp) compared with a smoking cessation static information app on continuous abstinence., Design: Automated double-blind randomised controlled trial with 6 months follow-up (2014-2015)., Setting: Smartphone-based., Participants: 684 participants (daily smokers of cigarettes, 18 years old or over) recruited passively from app stores in the USA, Australia, UK and Singapore, and randomised to one of two sub-apps., Interventions: Behavioural, decision-aid, smartphone application., Main Outcomes: Continuous abstinence at 10 days, 1 month, 3 months and 6 months., Results: Smokers who received the decision-aid app were more likely to be continuously abstinent at 1 month compared with the information-only app (28.5% vs 16.9%; relative risk (RR) 1.68; 95% CI 1.25 to 2.28). The effect was sustained at 3 months (23.8% vs 10.2%; RR 2.08; 95% CI 1.38 to 3.18) and 6 months (10.2% vs 4.8%; RR 2.02; 95% CI 1.08 to 3.81). Participants receiving the decision-aid app were also more likely to have made an informed choice (31.9% vs 19.6%) and have lower decisional conflict (19.5% vs 3.9%)., Conclusion: A smartphone decision-aid app with support features significantly increased smoking cessation and informed choice. With an increasing number of smokers attempting to quit, unassisted evidence-based decision-aid apps can provide an effective and user-friendly option to many who are making quit decisions without healthcare professionals., Trial Registration Number: ACTRN12613000833763., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods., Methods and Analysis: We will conduct a 2×2 factorial cluster randomised controlled trial with four arms: (1) video+prompt card, (2) decision aids+training, (3) video+prompt card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15-49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later., Ethics and Dissemination: We will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes., Trial Registration Number: ClinicalTrials.gov Identifier: NCT02759939., Competing Interests: Competing interests: RT reports a grant from the Patient-Centered Outcomes Research Institute (PCORI) during the conduct of the study and non-financial support from PCORI outside the submitted work. RT also reports ownership of copyright in several patient decision aids and a role as an editor of the text, ‘Shared Decision Making in Health Care’ but has not received any personal income connected to this ownership or role. RM, KZD, GS, DA, TF, DJJ, ZL, ALO, and TDT report a grant from PCORI during the conduct of the study. MB and KKU report personal fees from Dartmouth College during the conduct of the study. MBB reports a grant from PCORI and other payments from Dartmouth College during the conduct of the study. PB reports personal fees and non-financial support from Dartmouth College during the conduct of the study and non-financial support from Dartmouth College outside the submitted work. CCB reports personal fees and non-financial support from Dartmouth College during the conduct of the study. JN reports personal fees from Dartmouth College during the conduct of the study and non-financial support from PCORI outside the submitted work. MN reports personal fees and other payments from Dartmouth College during the conduct of the study. MN also reports a role as a healthcare provider and clinic representative in a clinic participating in the study. HLS reports a role as a developer of the AskShareKnow programme intervention components and related survey items that were adapted for use in the study but has not received any personal income connected to this role. LFS reports personal fees from Dartmouth College during the conduct of the study; grants from Bayer Health Care Inc., Teva Pharmaceuticals and Gilead Pharmaceuticals Inc. outside the submitted work; and personal fees from Hologic Inc. outside the submitted work. LT reports other payments from Dartmouth College during the conduct of the study. GE reports a grant from PCORI during the conduct of the study and personal fees from Emmi Solutions LLC, Washington State Health Department, Oxford University Press, the National Quality Forum, SciMentum LLC, EBSCO Health, & think LLC and ACCESS Federally Qualified Health Centers outside the submitted work. GE also reports ownership of copyright in the CollaboRATE measure of shared decision-making, the Observer OPTION measure of shared decision-making and several patient decision aids., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Men with prostate cancer require long-term follow-up to monitor disease progression and manage common adverse physical and psychosocial consequences of treatment. There is growing recognition of the potential role of primary care in cancer follow-up. This paper describes the protocol for a phase II multisite randomised controlled trial of a novel model of shared care for the follow-up of men after completing treatment for low-moderate risk prostate cancer., Methods and Analysis: The intervention is a shared care model of follow-up visits in the first 12 months after completing treatment for prostate cancer with the following specific components: a survivorship care plan, general practitioner (GP) management guidelines, register and recall systems, screening for distress and unmet needs and patient information resources. Eligible men will have completed surgery and/or radiotherapy for low-moderate risk prostate cancer within the previous 8 weeks and have a GP who consents to participate. Ninety men will be randomised to the intervention or current hospital follow-up care. Study outcome measures will be collected at baseline, 3, 6 and 12 months and include anxiety, depression, unmet needs, prostate cancer-specific quality of life and satisfaction with care. Clinical processes and healthcare resource usage will also be measured. The principal emphasis of the analysis will be on obtaining estimates of the treatment effect size and assessing feasibility in order to inform the design of a subsequent phase III trial., Ethics and Dissemination: Ethics approval has been granted by the University of Western Australia and from all hospital recruitment sites in Western Australia and Victoria., Results: of this phase II trial will be reported in peer-reviewed publications and in conference presentations., Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12610000938000.